This is an excerpt from Cynthia Connolly’s new book “Children and Drug Safety: Balancing Risk and Protection in Twentieth Century America” published in April 2018 by Rutgers University Press. Below, listen to audio of Connolly reading the excerpt, in three parts.
The development, use, and marketing of drugs for children in the 20th century is a history that sits at the interface of the state, business, health-care providers, parents, and children. Many of the drugs administered to children today have never been tested for safety and efficacy in the pediatric population. Although almost every recent American drug law was enacted because of a pediatric disaster, the drug-safety template historically improved for adults, not for children.
There have been major turning points in pediatric drug development, particularly in regard to children’s risk, rights, and protections in the evolving context of childhood, child-rearing, and family life. But those have been punctuated with nuances of race, class, gender—and political agendas. Nowhere were the issues starker than in the over-the-counter drug market, as the story of “candy” aspirin reveals.
A new drug for children
In 1947, the Plough Company, founded by entrepreneur Abe Plough, successfully reformulated an old, off-patent medication—aspirin—into a flavored, small-dose chewable tablet designed to appeal to children’s palates. Plough had made his fortune buying failing proprietary drug companies and marketing their products aggressively. Although Plough purchased St. Joseph in 1921, by the 1940s he had yet to see much profit.
The explosion of births after World War II provided him an opportunity. Plough put St. Joseph chemists to work developing a pediatric aspirin formulation attractive to children in color and taste. In September 1947, the company released the bright-orange St. Joseph Aspirin for Children amid a wave of creative marketing.
Although Plough used radio and, later, television to sell his products, he relied heavily on newspaper and magazine ads, particularly those in Parents magazine. Like the articles they surrounded, the families and scenarios in the St. Joseph ads presented an idealized, Madison Avenue vision of the American family, replete with overt gendered and classed messages. Mothers in well-appointed living rooms chatted while girls played with dolls and boys with trucks or action toys. The messages were also racially coded: Without exception, during this era, the children in St. Joseph Parents ads were white.
Despite this homogeneity, cultural messages were contradictory. Mothers looked relaxed, but copy implied that parenting was stressful and difficult. The ads were designed to tap into mothers’ anxieties by persuading them that postwar parenting was much more complex. As a result, the ads implied, children could face danger if a mother purchased a product that had not been scientifically formulated to accommodate her children’s physiological and psychological needs.
Plough’s new product achieved blockbuster status almost immediately. By the early 1950s, aspirin was the most common drug used in pediatrics, spurring Bayer and other manufacturers to launch competing versions. Even Benjamin Spock was not immune: He didn’t mention children’s aspirin in the 1940s editions of his book, but gave it prominent acknowledgment by the mid-1950s.
By the 1950s, low-dose, flavored aspirin was the number-one drug ingested by children, far outstripping its chief competitor, penicillin. Plough’s profits increased by double digits, in some years by as much as 50 percent.
If the narrative had ended here, the candy aspirin story would be a reification of American capitalism’s dynamism and societal benefits. But an unintended consequence soon appeared. Within a few years the American Academy of Pediatrics (AAP) documented a dramatic increase in aspirin poisoning in young children. The statistics seemed irrefutable: By 1951, three years after St. Joseph Aspirin for Children became available, preschool-age children represented 80 percent of aspirin deaths.
Plough’s marketing strategy had clearly worked: Children loved the taste of St. Joseph Aspirin for Children.
But nothing in Plough’s advertisements mentioned the importance of keeping it away from toddlers and preschoolers, and many parents may not have realized the threat from an overdose. They were undoubtedly horrified to learn that a toxic dose of aspirin could cause ringing in the ears, sleepiness, rapid and deep breathing, vomiting, and vision problems. An especially high dose could result in seizures, coma, even death.
Parents even sometimes inadvertently overdosed children. There was no mandate for a standardized children’s aspirin preparation. Each company decided how much acetylsalicylic acid to put in a tablet. St. Joseph, for example, sold a 1.25-grain tablet (80 mg), whereas Bayer’s was 2.5 grains (160 mg). Parents needed to read each label carefully. This confusion worried the AAP, which publicized the problem. As soon as the organization reported that 50 percent of accidents in children were poison-related, pediatricians, nurses, and public-health officials began tracking all accidental ingestions in children. In most instances, aspirin topped the list.
Despite evidence mounting in the news media and professional literature, as well as from FDA field agents, the aspirin industry, with Plough in the lead, denied any safety problem with children’s aspirin. If any action was needed at all, Plough executives argued, it was simply parental education.
Other companies in that market agreed. Just as the tobacco industry had begun doing with regard to health risks from cigarettes, aspirin manufacturers shaped the debates concerning aspirin poisoning using similar tactics. Any problems resulting from product use were the fault of the individual, not the product; in the case of aspirin, this meant poor parenting.
The Conference on Accidental Aspirin Poisoning
Growing concerns about candy aspirin poisoning led the FDA to convene a meeting in February 1955. The FDA, AAP, and American Medical Association (AMA) leaders, accompanied by vocal supporters from the American Public Health Association, hoped to succeed on two major issues: a label warning parents to keep aspirin bottles away from young children and a standard, industry-wide dosage. Aspirin makers arrived at the meeting hoping to forestall with their presence what one trade journal called “drastic and unrealistic measures,” such as banning flavored aspirin, which had been proposed by some physicians.
The aspirin industry got its wish. Despite heavy pressure from the FDA, the only concrete conference result was a recommendation that industry voluntarily consider different packaging. Industry tentatively agreed to an aspirin warning label, but no timeline was outlined, nor wording specified.
Several months after the conference the AMA Committee on Toxicology published a report in the Journal of the American Medical Association acknowledging that many types of drug manufacturers increasingly sought to appeal to children’s palates. Because aspirin was the most widely used, however, available in most homes, its candy formulations caused the most accidental ingestions.
According to AAP, the problem was not parents not reading directions; rather, youngsters aggressively hunted for the aspirin. As a result, significant parental diligence was necessary to prevent access by the determined toddler or preschooler. As numbers of aspirin-poisoned children continued to grow, one pediatrician, Jay M. Arena, decided to act. By the 1950s, Arena was one of the nation’s leading pediatric poison experts. After two children under age five died in one week from an overdose of “candy aspirin,” a frustrated Arena called Abe Plough himself.
Plough was initially reluctant to do anything, admitting to Arena he was “scared to death” that taking any action would negatively affect sales for his leading product. Arena responded with an appeal, explaining that St. Joseph Aspirin for Children could differentiate itself by demonstrating a commitment to child well-being, and, as proof of the company’s largesse, promote its financial investment toward a protective barrier on these bottles.
Plough assigned one of his executives to work with Arena to develop what’s known today as a safety cap. In the first advertisement for the safety cap–protected St. Joseph Aspirin for Children, in the December 1958 Parents, the company featured it prominently. Within a year Bayer was advertising its safety-capped children’s aspirin, too. However, mortality rates from aspirin poisoning continued to rise. The determined toddler or preschooler could overcome the barrier. In an effort to educate parents, the FDA, poison control centers, and pharmacists’ associations instituted public-health campaigns focused on aspirin-poison prevention.
Although manufacturers had, by 1960, agreed to standardize the amount of aspirin in one tablet, they refused to budge on limiting the number of pills per bottle. They faced little opposition. In the context of other concerns about the pharmaceutical industry, such as the thalidomide crisis, the regulatory energy surrounding children’s aspirin fell by the wayside in the short term.
Politics in the medicine cabinet
The aspirin issue roared to life again a few years later when, in 1964, Consumer Reports publicized its concern about “candy aspirin” poisoning. The next year Missouri Representative Leonor K. Sullivan introduced a bill that prohibited interstate sale of children’s aspirin. The effort received publicity, putting the issue back in the legislative spotlight.
A few weeks later, investigative journalist Jack Anderson wrote in a Washington Post column about his two nieces nearly dying from flavored aspirin overdoses. And soon after, South Dakota Senator George McGovern introduced the Children’s Aspirin Amendment of 1965, which did not ban flavored aspirin entirely but rather limited the number of tablets in a bottle.
Evidence of aspirin’s dangers on young children continued to mount. In 1965, the National Clearing House for Poison Control Centers received 34,483 accidental drug ingestion reports by children under five, of which 16,328 (47 percent) involved aspirin or other salicylates. In 1966, poison control centers documented that 88 percent of the nearly 11,000 children under age five treated in an emergency room for aspirin ingestion had overdosed on a flavored formulation.
Mortality figures from flavored aspirin motivated support for several bills expanding federal control over hazardous substances. A series of hearings regarding the Child Safety Act (soon renamed the Child Protection Act) were scheduled for 1966. Among many new powers, the potential law would provide the FDA statutory authority to regulate all aspects of manufacturing, bottling, and labeling of children’s aspirin.
The 1966 Child Protection Act hearings
Any hope that children’s aspirin makers harbored for avoiding negative publicity from the Child Protection Act hearings was dashed on March 21, 1966, when President Lyndon Johnson issued a statement directly addressing them, calling specifically for limiting amounts available in retail packages and requiring safety caps.
Aspirin makers seemed stunned by the negative attention.
Debate over the need for more federal oversight became the hearings’ focal point. The only consensus occurred on day one, when everyone involved agreed to act in a way that benefited children. But it was quickly clear that there was little accord over what constituted the best interests of children, who were seen as valuable and negotiable political property.
One of the first witnesses, new FDA commissioner James L. Goddard, argued stridently that toddlers and preschoolers were best served by mandating safety caps and limiting pills per bottle. Although he acknowledged the broad range of potentially toxic household products, he was adamant that robust data suggested that “the greatest danger [to children in the home] is posed by the flavored children’s aspirin.” Goddard even supplied the committee with a number of different safety caps to practice opening.
Representative Sullivan also testified, imploring colleagues not to heed the numerous forthcoming witnesses from the aspirin industry and reminding legislators that young children overdosed on aspirin in a ratio of four to one relative to other medications.
Aspirin manufacturers, led by Plough, and related trade organizations also testified. Plough’s representative, like several previous speakers, emphasized that industry—not children—needed protection and such protection should come from governmental regulation. He also told the committee that St. Joseph Aspirin for Children, voluntarily and before any others, safety cap-protected its product. He declared that Plough wanted to cooperate, but that this new bill went too far.
Industry participants also challenged the data and the FDA’s motives for seeking new regulation. By the end of aspirin industry’s testimony, subcommittee members who had previously supported the FDA now felt angry and betrayed, and the tone was very different when Goddard returned to the Hill. Industry had successfully shifted the issue from discussing how best to use epidemiological evidence to protect young children, to the need to reign in a rogue federal agency. Goddard’s detailed, point-by-point rebuttal mostly fell on deaf ears.
Although Congress did pass the Child Protection Act, the proposal to limit tablets in a bottle and other aspirin-related mandates like safety caps were dropped. Policymakers declared that the problems could be addressed with a voluntary FDA-industry conference.
Mandating safety barriers
The Child Protection Act congressional hearings showed how easily industry had shifted the terrain from discussions surrounding protecting children to safeguarding itself. Despite additional negative press, the mood was celebratory for aspirin makers in December 1966. In the past year, they had fended off regulations and embarrassed FDA commissioner Goddard.
Then came the 1967 conference, which included representatives from groups active in the poison-control movement, aspirin manufacturers, and the FDA. In his opening remarks, Goddard admonished stakeholders that he would not hesitate to return to Congress if he determined industry was not participating in good faith. He had been assured that if problems regarding safety caps and mandatory limiting of tablets per container could not be solved, Congress would be willing to consider future legislation.
Perhaps fearing Goddard would make good on his threat, industry quickly reached consensus regarding a pills-per-bottle standard. Companies also agreed to support a national poison education campaign and acquiesced to the FDA request to fund a subgroup, the Subcommittee on Safety Closures, to determine an ideal safety device that all manufacturers could agree to adopt.
Between 1967 and 1971, the Subcommittee on Safety Closures met formally eight times. The group oversaw a series of industry-funded studies that enrolled hundreds of young children, mothers, and older people to identify a safety cap that prevented children from opening the bottle but made it as easy as possible for adults.
The FDA and members of the subcommittee came to Capitol Hill in October 1969 to report their progress during Senate hearings for a new bill: The Poison Prevention Packaging Act. Stakeholders eventually cobbled together enough support to pass the legislation, which required that all potentially toxic household products carry child-safety closures within a specified period of time. Aspirin was the first product covered by the new law, with packaging to go into effect by August 1973.
By the mid-1970s, aspirin mortality rates in young children had declined significantly, thanks to safety caps and other poison-preventing measures. Nonetheless, many children got sick and a number died because of the protracted delay in mandating this important poison-prevention measure. In an era rife with child-protection rhetoric, debates surrounding children’s aspirin in the years between 1948 and 1973 reveal what can happen when recommendations for children’s well-being challenge corporations’ economic well-being.
Cynthia Connolly holds the Rosemarie B. Greco Term Endowed Associate Professorship in Advocacy and is an associate professor of nursing in the School of Nursing. She is also associate director of the Barbara Bates Center for the Study of the History of Nursing and the co-faculty director of the Field Center for Children’s Policy, Practice & Research in the School of Social Policy & Practice. The text above is excerpted from “Children and Drug Safety: Balancing Risk and Prevention in Twentieth-Century America” (New Brunswick: Rutgers University Press, 2018.) ©Cynthia A. Connolly. Reprinted with permission from Rutgers University